Dyufalak

General characteristics. Structure:

100 ml of solution contain:
active agent: lactulose of 66,7 g.
excipient: the water purified to 100 ml.

Description: transparent viscous liquid from colourless to light yellow with a brownish shade of color.

Pharmacological properties:

Pharmacodynamics. Has hyperosmotic laxative effect, stimulates an intestines peristaltics, improves absorption of phosphates and Sa2+ salts, promotes removal of ions of ammonium.

Lactulose is split by an indestinal flora of a large intestine on low-molecular organic acids that leads to decrease рН both to increase in osmotic pressure and, as a result, increase in volume of intestinal contents. The specified effects stimulate a peristaltics of intestines and exert impact on a chair consistence. The lock disappears and the physiological rhythm of emptying of a large intestine is recovered.

At hepatic encephalopathy or a hepatic coma the effect is attributed to suppression of proteolytic bacteria by means of increase in quantity of acidophilic bacteria (for example, lactobacilli), to transition of ammonia to an ionic form due to acidulation of contents of a large intestine, to bowel emptying owing to decrease рН in a large intestine and osmotic effect, and also to reduction of nitrogen-containing toxic substances by stimulation of the bacteria utilizing ammonia for bacterial proteinaceous synthesis.

Lactulose as prebiotichesky substance strengthens growth of beneficial bacteria, such as bifidobacteria and lactobacilli while there is possible a suppression of growth of potentially pathogenic bacteriums, such as Clostridium and Escherichia coli that provides more favorable balance of an indestinal flora.

Pharmacokinetics. Absorption is low. After intake reaches a large intestine in not changed look where it is split by an indestinal flora. It is completely metabolized at doses to 40-75 ml; at higher dosage it is partially removed in not changed look.

Indications to use:

— Lock: regulation of a physiological rhythm of emptying of a large intestine.

— A chair softening in the medical purposes (hemorrhoids, states after a large intestine operation and in an anus).

— Hepatic encephalopathy: treatment and prevention of a hepatic coma or prekoma.

Route of administration and doses:

Drug is intended for intake.

Solution of lactulose can be accepted both in divorced, and in not divorced look. It is necessary to swallow the accepted single dose at once, without detaining in a mouth.

All dosages have to be selected individually.

In case of purpose of a single daily dose, it needs to be accepted at the same time, for example, during a breakfast.

During therapy purgatives recommend to accept enough liquid (1,5-2 liters that is equal to 6-8 glasses) in day.

Dosage at treatment of a lock or for a chair softening in the medical purposes:

The daily dose of lactulose can be accepted once, or having divided it into two, using a measured glass.

The initial dose can be corrected to a maintenance dose depending on reaction to administration of drug. The therapeutic effect can be shown in 2-3 days after the beginning of administration of drug.

Age                          Initial               Supporting
                                       daily dose         daily dose

Adults and teenagers   of 15-45                      ml 15-30 ml
Children of 7-14 years                       of 15                      ml 10-15 ml
Children of 1-6 years                      of 5-10                        ml 5-10 ml
Children till 1 year                  to 5 ml                        to 5 ml

Dosage at treatment of a hepatic coma and prekoma (adult):

Initial dose: 3-4 times a day on 30-45 ml.

Then pass to individually picked up maintenance dose so that the soft chair was at most 2-3 times a day.

Features of use:

In case of lack of therapeutic effect within several days it is necessary to consult with the doctor.

Lactulose has to be appointed with care to patients with a lactose intolerance.

It is necessary to consider that Dyufalak® may contain insignificant amounts of the connected sugars (for example, lactose, a galactose, an epilaktoza and fructose).

At reception of the dosage recommended for treatment of a lock, the content of sugar should not represent problems for patients with a diabetes mellitus. At treatment of a hepatic coma usually appoint higher doses of drug, and content of sugar in it it has to be considered concerning patients with a diabetes mellitus.

Patients with rare inborn disturbances, such as intolerance of a galactose or fructose, deficit of lactase of falls (Sami) or malabsorption of glucose galactose, should not use this medicine.

At treatment of children purgatives have to be applied in exceptional cases and under observation of the doctor. It is necessary to consider that during treatment there can be frustration of a reflex of emptying.

Influence on ability to driving and other mechanisms

Use of the drug Дюфалакâ does not influence or exerts insignificant impact on ability to driving and mechanisms.

Side effects:

In the first days of reception of lactulose emergence of a meteorism is possible. As a rule, it disappears in several days. In case of use of the raised doses for a long time at treatment of hepatic encephalopathy at the patient disturbances of electrolytic balance owing to diarrhea can develop.

Messages on side effects had spontaneous character, and for exact assessment of frequency of cases of the available data it is not enough.

Disturbances from digestive tract:

Meteorism, abdominal pain, nausea, vomiting. At reception of very high doses — diarrhea.

Other disturbances:

Electrolytic imbalance owing to diarrhea.

Interaction with other medicines:

Researches on interaction with other medicines were not conducted.

Contraindications:

— galactosemia;

— intestinal impassability;

— hypersensitivity to any component of drug.

With care

— lactose intolerance;

— the patients with a hepatic coma suffering from a diabetes mellitus;

— the rectal bleedings which are not diagnosed;

— kolostoma, ileostoma.

Use at pregnancy and during breastfeeding

No influence on a fruit or the baby as system impact of lactulose on the pregnant woman or the feeding woman is insignificant is supposed.

Дюфалак® it is possible to appoint during pregnancy and during breastfeeding.

Overdose:

Symptoms: at reception of very high dose the abdominal pain and diarrhea are possible.

Treatment: the termination of administration of drug or reduction of a dose and correction of an electrolytic imbalance in case of big loss of liquid owing to diarrhea or vomiting.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Syrup of 667 mg/ml.

200 ml, 500 ml or 1000 ml in a bottle from polyethylene of high density of white color with the screw-on cover from polypropylene with control of the first opening. Over a cover the cap (from polypropylene) serving as a measured glass is put on. On a bottle paste the label with the application instruction.

On 15 ml in one-time bags from polyethylene and aluminum foil. On 10 bags together with the application instruction in a pack cardboard.